Category Archives: PAT and QbD

On January 25, 2012, I attended an excellent session at the IFPAC Conference where a series of presenters including Lonza, Hovione, Merck, Pfizer, and Bristol-Myers Squibb presented the value of Process Analytical Technology (PAT) and Quality by Design (QbD) within a CRO/CMO (Contract Research Organization/Contract Manufacturing Organization). Continue reading →

Crystallization and precipitation are critical processing steps in chemical development. They can serve as purification and separation steps, and have implications on the yield, purity and particle size distribution. Even though crystallization has advanced significantly over the past decade, many chemists have such short deadlines that they must base everyday decisions on past experience rather than understanding the crystals in situ. Due to the complexity of crystallization, a process may be developed simply by crashing solids out of solution and transferring a non-robust process with inconsistencies in the yield, purity and particle size distribution. Continue reading →

Previously, we looked at a case study that neatly illustrated the concept that slow supersaturation generation often results in a growth dominated process that is typically repeatable. As a rule of thumb, slow cooling works great – but its main drawback is the extended cycle times that often result. To overcome this problem, a common technique often used is non-linear cooling.

If we dive a little bit deeper into the governing equations of crystal growth and nucleation.. Continue reading →

Last week, I attended the VisiMix International Conference in Boston, MA. Held at the Colonnade Hotel, the conference focused on the influence of mixing unit operations in your process and featured presentations by well-respected leaders in the chemical and pharmaceutical industries on topics including: Continue reading →

Recently, I met several scientists who did not realize Lasentec® (Lasentech) was acquired by METTLER TOLEDO. It is hard to believe that it has already been 10 years since METTLER TOLEDO acquired Lasentec® and became the world leader for inline particle characterization technology!